Dr Tyson on the Potential Role of TARA-002 in BCG-Naive High-Grade NMIBC

“A lot of practices run out [of BCG. If that's the case, then we need alternative immunotherapies, and [TARA-002] is one of those alternatives. It meets that unmet need for high-risk, CIS patients that need some type of intravesical therapy.”

Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic, discussed how TARA-002, a TLR2/NOD2 agonist and novel immunopotentiator derived from Streptococcus pyogenes, could address unmet needs for patients with BCG-naive high-grade non–muscle-invasive bladder cancer.

The persistent shortage of BCG is a major challenge in the management of patients with BCG-naive, high-risk NMIBC, Tyson began. Although BCG remains the standard intravesical therapy for these patients, many urologic oncology practices routinely experience limited supply, creating barriers to delivering guideline-recommended treatment. This issue is not isolated to individual centers but is widely encountered across the bladder cancer field, underscoring the urgent need for alternative therapeutic options.

To address these shortages, some institutions have relied on participation in clinical trials to secure access to additional BCG formulations, Tyson said. Studies such as the phase 3 S1602 trial (NCT03091660) have provided access to the Tokyo strain of BCG, while the phase 3 SunRISe-3 trial (NCT05714202) has offered the Danish strain, he explained. More recently, recombinant BCG developed by ImmunityBio has become another potential source of therapy, he added. However, these avenues are not universally available, and maintaining a consistent supply of BCG remains an ongoing challenge for many practices, he noted.

Given the expectation that BCG shortages are likely to persist in the foreseeable future, there is increasing recognition that alternative immunotherapeutic approaches are needed, Tyson said. Novel intravesical therapies such as TARA-002 have the potential to fill an important treatment gap for patients who require bladder-preserving therapy but are unable to receive standard BCG because of limited availability, he said. Such therapies are particularly relevant for patients with high-risk CIS, who require effective local treatment to reduce the risk of disease progression and recurrence, he concluded.